Effects of the Contraceptive Implant in Women With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

— SCD CURE  

Official title:

Effects of the Contraceptive Implant in Women With Sickle Cell Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730205
• Other study ID #: 855708
• Status: Recruiting
• Phase: Phase 4
• Start date: June 8, 2023
• Est. completion date: February 15, 2025

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: Arden McAllister, MPH
• Phone: 267-785-8044
• Email: arden.mcallister[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises, quality of life, and hematologic parameters in women with SCD.

Description:

Sickle cell disease (SCD) is the most common inherited blood disorder in the United States, affecting 100,000 primarily Black people. The disease is characterized by chronic pain and infection, and ultimately reduces life expectancy by 20 years compared to people without SCD. Given the importance of effective contraception for women with sickle cell disease, as well as previously demonstrated therapeutic benefits of hormonal contraception, the etonogestrel implant may be an optimal method of contraception for women with SCD.

This study aims to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises, quality of life, and hematologic parameters in women with SCD.

This is a crossover study. Participants will be observed over two phases: 1) a 3-month phase with no hormonal contraceptive intervention and 2) a 6-month phase with the progestin implant. During the phase with no hormonal contraceptive intervention, participants must be willing to be abstinent or use a barrier method, or they must have had a permanent contraception procedure such as a tubal ligation or salpingectomy or be using the copper intrauterine device.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female aged 18-45

• Diagnosis of sickle cell disease (SS or SB0)

• Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months

• Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month required for all hormonal contraception prior to enrollment in the study.

• Access to a device with text messaging capability

• Must be able to read and understand English

• Willing to comply with study procedures

Exclusion Criteria:

• SC Disease

• Use of Depo Provera in the past 6 months

• Changes to sickle cell medications in the past 3 months

• Contraindications to use of Nexplanon device as per clinical standards

• Currently pregnant or pregnant within the last month or seeking to become pregnant

• Currently breastfeeding

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• Nexplanon 68 MG Drug Implant
Progestin contraceptive device

Locations

Country	Name	City	State
United States	Penn Medicine University City	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of vaso-occlusive crises	Self-reported pain crises, discrete pain episodes will be separated by at least 2 weeks	9 months